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The Impact of Airway Allergic Diseases on Children's and Parents' Quality of Life

ClinicalTrials.gov IDNCT06535087

PhaseNot Applicable

Enrollment600

SponsorWenjing Zhou

Age5 Years

SexALL

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Conditions studied

Pediatric Asthma, Rhinitis, Allergic, Quality of Life

About this study

This prospective observational study aims to assess the health-related quality of life (HRQoL) of 200 children (ages 5-16) with bronchial asthma, allergic rhinitis, or both, and their 200 parents, comparing 100 children receiving specific immunotherapy with 100 receiving routine treatment. Using EQ-5D-Y(EuroQol five dimensions questionnaire, youth version), disease-specific scales, and newly developed Chinese versions of EQ-5D-Y and EQ-HWB-S (EuroQol health and well-being questionnaire, short version), the study evaluates HRQoL changes over 1 and 2 years and explores the impact on caregiver burden and spillover effects. A control group of 100 healthy children and their parents will be included. Data collection involves baseline and follow-up surveys, clinical data from medical records, and statistical analyses to compare treatment effects and validate measurement tools.

Interventions

Drug: Subcutaneous immunotherapy / Standard Treatment for Asthma and Rhinitis — 1. Subcutaneous Allergen-Specific Immunotherapy: * Pre-treatment: Omalizumab subcutaneous injection, with the total IgE level serving as the basis for calculating the dosage for children. The appropriate dosage of omalizumab (each dose ranging from 75 to 600 mg) and administration frequency (once every 4 weeks) are determined based on the baseline IgE (IU/mL, measured before the start of treatment) and body weight (kg). * Mite Allergen Preparation: (Antergen/Alutard) 2. Standard Treatment: * Asthma: Inhaled corticosteroids (ICS) combined with long-acting beta-2 agonists, leukotriene receptor antagonists. * Allergic Rhinitis: Oral antihistamines, nasal antihistamines, nasal corticosteroids, anti-leukotriene drugs, cromolyn sodium, decongestants (oxymetazoline hydrochloride), and nasal saline irrigation.

Primary outcomes

Asthma control level for asthmatic children (Baseline 1 week before treatment; 2 follow-up every 12 months)
Severity assessment of allergic rhinitis (Baseline 1 week before treatment; 2 follow-up every 12 months)
EQ-5D-Y-3L for assessing health-related quality of life (Baseline 1 week before treatment; 2 follow-up every 12 months)
EQ-VAS for assessing health-related quality of life (Baseline 1 week before treatment; 2 follow-up every 12 months)
PAQLQ for assessing health-related quality of life in children with asthma (Baseline 1 week before treatment; 2 follow-up every 12 months)
JRQLQ-No. 1 for assessing health-related quality of life in children with allergic rhinitis (Baseline 1 week before treatment; 2 follow-up every 12 months)

Eligibility information

Inclusion Criteria: 1. Children: 1. Aged 5-16 years; 2. Diagnosed with bronchial asthma, allergic rhinitis, or both (persistent, duration ≥4 weeks) by a respiratory or allergy specialist; 3. Guardian has signed the informed consent form; 4. Able to understand and complete the questionnaire; 5. Outpatients or inpatients at the Pediatrics Department of Renji Hospital in Shanghai. 2. Parents: 1. The primary caregiver of the enrolled child; 2. Accompanied the child to the hospital on the day of the visit; 3. Signed the informed consent form; 4. Able to understand and complete the questionnaire. Exclusion Criteria: 1. Children: 1. Poor compliance; 2. Already received specific immunotherapy at another hospital; 3. Unable to independently read and complete the questionnaire; 4. Lost to follow-up or discontinued treatment. 2. Parents: 1. Unwilling to sign the informed consent form; 2. Unable to complete the questionnaire due to physical condition or educational level.

Study locations

Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, Shanghai Municipality 200127 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.